AQA/Data Reviewer – Chemistry
Job Description
**Job Title:** AQA/Data Reviewer – Chemistry
**Location:** Decatur, Illinois
**Contract Type:** Full-Time
**Position Overview:**
The **QA Data Reviewer** in the Chemistry department ensures the highest quality in data accuracy, conformance to procedures, and overall integrity from the laboratory. This role involves thorough review of all analytical data, raw data, and laboratory documentation to guarantee alignment with cGMPs (current Good Manufacturing Practices) and company SOPs.
**Key Responsibilities:**
* **Data Integrity:** Review all source data, summary reports, and laboratory documentation for accuracy and compliance with cGMP standards.
* **Documentation Review:** Ensure all laboratory data and calculations conform to SOPs and specifications.
* **Electronic Data Audit:** Perform detailed reviews of electronic data audit trails, verifying all signatures and ensuring data integrity.
* **Collaboration:** Work closely with analysts to correct data/documentation issues, ensuring completeness and reference accuracy.
* **Compliance Assurance:** Verify that all laboratory testing is conducted in accordance with SOPs, cGMPs, and GLPs (Good Laboratory Practices).
* **Process Improvements:** Identify and implement data security, integrity, and efficiency improvements.
* **Mentoring:** Assist in training and mentoring junior analysts, fostering a culture of accuracy and compliance.
* **Cross-Departmental Interaction:** Regularly collaborate with Production, QA, RA, R&D, and Validation teams.
**Qualifications & Experience:**
* **Education:** Bachelor’s degree in Life Sciences (e.g., Chemistry, Biochemistry, or related field) or Pharmacy.
* **Experience:** Minimum of **6 years of experience** in an industrial laboratory, specializing in sterile dosage forms within the pharmaceutical industry.
* **Skills:** Strong conceptual, analytical, and problem-solving skills with proficiency in Microsoft Office (Excel/Access).
**Job Prerequisites:**
* **Experience:** Must have worked in the pharmaceutical industry for at least 6 years with specific experience in **Sterile Injectables** and **QC/laboratory data review**.
* **Certifications:** Knowledge and experience in working within cGMP environments.
**Required Citizenship / Work Permit / Visa Status:**
* **Eligible Candidates:** U.S. Citizen, Green Card Holder, TN Visa, H1B Transfers, OPT EAD.
**Interview Process:**
* **Phone screening** (via Microsoft Teams) with Quality Control Leadership for remote candidates.
* **On-site interview** for candidates within driving distance or after initial screening.
**Benefits:**
* Full benefits package including medical, dental, vision insurance, STD/LTD, 100% 401K match up to 4%, PTO, 8 paid holidays, health savings plans, and life insurance.
**Relocation Expenses:**
* Evaluated on a case-by-case basis.
Job Type: Full-time
Pay: Up to $80,000.00 per year
Benefits:
* 401(k)
* 401(k) matching
* Dental insurance
* Health insurance
* Life insurance
* Paid time off
* Vision insurance
Schedule:
* 8 hour shift
* Day shift
* Monday to Friday
Ability to Commute:
* Decatur, IL (Preferred)
Work Location: In person
